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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of type 1 diabetes for at least 1 year
Insulin pump use for at least 2 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeeks
Awards & highlights
Study Summary
This trial will help researchers understand how a very low carbohydrate diet impacts teens with type 1 diabetes, so that they can better understand the safety and efficacy of this diet for this population.
Who is the study for?
Adolescents with Type 1 Diabetes who can check blood ketones daily, use a continuous glucose monitor and insulin pump, and are willing to follow study diets. They must have an HbA1c level <10%, diagnosed for at least 1 year, and agree to effective contraception if applicable. Those on weight loss meds recently or with conditions affecting glucose metabolism or unstable psychiatric disorders cannot join.Check my eligibility
What is being tested?
The trial is studying the effects of a very low carbohydrate diet compared to a standard one in young people with Type 1 Diabetes. It aims to understand how these diets affect metabolism and brain function, which will inform safe dietary advice for managing their condition.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include changes in blood sugar levels that could lead to hypoglycemia or ketoacidosis due to the dietary intervention's impact on insulin requirements.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with type 1 diabetes for over a year.
Select...
I have been using an insulin pump for at least 2 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glucose
Secondary outcome measures
Hyperglycemia
Time spent with hypoglycemia.
Other outcome measures
Human Factors
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: low carbohydrate dietExperimental Treatment1 Intervention
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories.
Group II: standard carbohydrate dietActive Control1 Intervention
In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake.
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,421 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,572 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your average blood sugar level over the past 2-3 months is too high.I am a man who can father children and will use contraception.I have signed the consent form, or my parent has if I'm under 18.You have unstable mental health conditions, including eating disorders.I am currently using medication to lower my blood sugar, not including insulin.My gender identity does not affect my eligibility.I have a condition that affects my blood sugar and insulin levels.I have not taken weight loss medications in the last 6 months.My BMI is less than 19.My BMI is below the 5th percentile for my age.I have been diagnosed with type 1 diabetes for over a year.I have been using an insulin pump for at least 2 months.I weigh less than 108 pounds.
Research Study Groups:
This trial has the following groups:- Group 1: low carbohydrate diet
- Group 2: standard carbohydrate diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical investigation accommodating seniors aged 60 and above?
"This clinical trial is targeting participants aged between 12 and 21 years old. In comparison, there are 216 studies for those under 18 and 921 for people over 65."
Answered by AI
Am I eligible to sign up for this experiment?
"The requirements to join this clinical trial are that participants must have type 1 diabetes, be following a low-carbohydrate diet, and fall between the ages of 12 and 21. Up to 20 individuals may participate in the study."
Answered by AI
What is the maximum capacity for enrollees in this research endeavor?
"Affirmative. Clinicaltrials.gov outlines that this clinical trial, which was launched on July 29th 2021, is actively seeking individuals to participate in the study. At present, only 20 participants are needed from a single location."
Answered by AI
Are there any vacancies that participants can still enroll in for this experimentation?
"Affirmative, the clinicaltrials.gov database outlines that this medical investigation is actively in search of participants, first being posted on July 29th 2021 and most recently updated on June 1st 2022. 20 individuals must be recruited from a single location."
Answered by AI
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